Regulatory Open Forum

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation. 

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I am well aware that this situation exists in the industry; I'm not in a position to say how widespread.  However, I am in a position to say it is not uncommon. :(

That said, when an RA person asks another RA person about the documents that need to be in a technical file to support CE Marking, I think something is wrong with that picture. I think there are a number of RA professionals who don't know any better, from having spent time only in environments such as you describe.  I would like for every RA professional to know better, and this forum is a place where they can have the opportunity to learn.

I subscribe to the Four Agreements, so I would also like to see every RA professional who knows better be impeccable in their words, whenever the opportunity presents itself.  And certainly this forum provides that opportunity as well.

Maybe that would be a good multiple choice question for the RAC.  Which of  these documents are required to be in the technical file to support CE Marking?  None of the above.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I am well aware that this situation exists in the industry; I'm not in a position to say how widespread.  However, I am in a position to say it is not uncommon. :(

That said, when an RA person asks another RA person about the documents that need to be in a technical file to support CE Marking, I think something is wrong with that picture. I think there are a number of RA professionals who don't know any better, from having spent time only in environments such as you describe.  I would like for every RA professional to know better, and this forum is a place where they can have the opportunity to learn.

I subscribe to the Four Agreements, so I would also like to see every RA professional who knows better be impeccable in their words, whenever the opportunity presents itself.  And certainly this forum provides that opportunity as well.

Maybe that would be a good multiple choice question for the RAC.  Which of  these documents are required to be in the technical file to support CE Marking?  None of the above.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.

I've actually studied up on this a bit.

The term seems to be an old engineering term, not unique to the medical device industry.  I have found references to its use in shipbuilding and building construction, always in the US.  Some of the references I've tracked down predated the Medical Device Amendments by several decades.

I would guess the term came into widespread use about the time that engineering came into its own in the US, which is to say, during and shortly after WWII.  I(Some book I was reading recently described the 1960s as "the heyday of the American engineer.") I also exchanged some emails about the term with someone at one of the big NBs, who said he thought this was an Americanism, as device companies in other countries with which he had had experience did not use it, but instead referred to "technical documentation," consistent with the language in the MDD/MDR.  This would also be consistent with the connection to WWII.

I have found a number of problems related to use of the term, though of course none intrinsic to the term itself.  It can confuse people in the company, as well as create something of an RA/QA leadership credibility gap, when people are told repeatedly that the MDD/MDR requires that certain documents be maintained in the technical file, and then eventually they discover that the MDD/MDR doesn't even require a technical file, much less that any particular document be in one.  You can say that it's just a turn of phrase, but they won't believe you.  I don't really believe it, either.

It often seems that, the more people focus on what documents are "required" to be in the technical file, the less they focus on what David has correctly observed is the important thing...the content of those documents.

I have also described this term as the "US device engineer's security blanket."   I think I'll just leave everyone to ponder what I might mean by that, lol.

I'm just back from the RAPS EU workshop last weekend.  The fact that the speaker on technical documentation made a particular point (dedicated an entire slide to it) that the MDR makes no mention of "technical file" but referrs to "technical documentation" something like 250 times suggests to me that there are others who find use of the term somehow problematic as well.

Hello fellow RAPpers,

There have been some comments in several recent forum discussions pointing out that there is no "requirement" in either the MDD or MDR to create a Technical File.  The implication is that it is therefore incorrect to use the term Technical File.

The MDR does require technical documentation that is to be "drawn up" by the manufacturer.  The technical documentation is required to be "presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."(Annex II)

For years we have referred to the collection of technical documentation for each device organized to facilitate Notified Body review for CE marking as the device's Technical File.  It's true that the technical documentation may be more complex than a "file" and the documentation can be kept as hard copy, electronically, or a hybrid of both.  However, it seems to me that "Technical File" serves as the most universally recognized term with which to refer to this collection of technical documentation for each device. 

Just because the MDD and MDR don't require a Technical File per se does not mean that we cannot use the term to refer to our collection of technical documentation for each device organized to facilitate review for CE marking.  The  collection of technical documentation for each device will also have to be shared and kept up to date with the Notified Body and Authorized Representative.  It seems practical to have a term with which we are all familiar to refer to this collection of technical documentation.

I would like to hear other opinions on this matter.

Thanks, in advance, for your input.